EU is Center Stage in Cloning Drama as US Watches

These are the names of some of the “rock stars” playing a part in a controversial drama that has been dubbed “the cloning revolution.”

Yes, we’re talking about “barnyard rock stars” here — in this case, bulls and cows that have been been reproduced as clones or have been cloned, a process that creates identical copies of the original animal. Clones of other meat and milk animals such as pigs, sheep, and goats have also been produced.

It’s a heated tug of war, this novel reproductive technology that burst onto the public scene back in 1997 with the announcement of the birth of Dolly the sheep. The unsuspecting lamb made history by being the first mammal to be cloned from a cell taken from an adult mammal. Her debut unleashed a flurry of reactions, ranging from shocked delight to absolute dismay.

Pulling with all their weight on one side of the rope in this tug of war are opponents of cloning, who warn that the technology is inhumane and that the meat and milk from clones and their offspring pose possible food-safety risks. They also warn that not enough is known about the technology and its effects on the animals — or about the composition of the meat and milk from clones and their offspring.

“I’m not saying that the meat and milk from clones or their progeny are unsafe,” Jaydee Hanson, policy analyst on cloning and genetics at the Center for Food Safety, told Food Safety News. “But I am saying that the studies on this have been so inadequate that we can’t make a judgment.

Pulling equally hard on the other end of the rope are cloning supporters, as well as officials from the U.S. Food and Drug Administration, who say that meat and milk from cloned animals and their offspring are safe to eat.

Keying in on food-safety issues, veterinarian Don Coover, president of Kansas-based SEK Genetics, told Food Safety News that “down the road, cloning will be enormously important” in producing animals that are healthy, disease resistant, with improved nutritional attributes in their meat and milk, such as blends of proteins and fats that are more easily digested.

He refers to those advantages as “the real value of this technology going forward.”

This tug of war over cloning is currently going on in the European Union, and because meat and dairy-related exports are so important to the U.S. livestock economy, those who support and oppose this relatively new reproductive technology are watching the rope with keen interest.

A decision is expected by the end of this month. But in true EU style in matters of all things biotech, the progress toward any decision at all has been anything but smooth.

Cloning 101

SEK’s Coover said that before going any further with this topic, it’s important to understand the difference between what is called “somatic cell nuclear transfer” and “transgenic cloning.”

Put simply, somatic cell nuclear transfer involves putting the nucleus of a cell from an animal’s body into a female egg cell that has had its nucleus removed. This produces what scientists call a “clonal embryo.”

Chemicals or electricity are then used to start the clonal embryo developing. When the clonal embryo is put into the uterus of a female animal and brought to term, the animal that is born is a clone. Its genes are identical to those of the animal that the original body cell was taken from.

This process produces a duplicate of the original animal. An example is creating a clone (an identical version) of a superior beef or milk cow. Texas-based ViaGen describes the animal that has been cloned and the clone of that animal as “identical twins separated by time.”

In contrast, transgenic cloning involves transferring a gene, or genes, from one animal into another animal. An example of this are the AquaAdvange salmon, which are essentially Atlantic salmon with an inserted growth gene from a Chinook salmon and an antifreeze gene from an ocean pout. These salmon grow twice as fast as typical Atlantic salmon and require approximately 10 percent less feed to achieve the same weight.

If FDA gives these genetically modified salmon a thumbs up, they will be the first genetically engineered food animal approved for human consumption.

In 2008, the U.S. Food and Drug Administration gave the meat and milk from cow, pig, and goat clones (but not sheep) and their offspring a thumbs up, saying there are no significant differences between those food products and those of animals produced conventionally or through other reproductive technologies such as artificial insemination or embryo transplant.

Voluntary moratorium

With an eye to export markets, as well as to consumer qualms about cloning, the FDA requested a voluntary moratorium, asking livestock breeders and producers to keep food products from cloned animals and their offspring out of commerce.

Although the FDA moratorium is no longer in effect, the USDA has been encouraging the cloning industry and meat producers to maintain the voluntary moratorium — but for cloned animals only. In other words, the moratorium does not apply to meat and milk from the offspring of clones.

In an email to Food Safety News, Michael Martin, spokesman for U.S. meat giant Cargill, said the company supports the USDA’s extended voluntary moratorium on the sale of meat and milk from cloned animals.

“However, there is no moratorium on meat and milk products from offspring from cloned animals,” he said, pointing out that the company believes that makes sense “given that science has proven there is no genetic (DNA) difference between these animals and offspring of traditionally produced animals.”

He also said that because the U.S. has no mandatory national animal identification system to track the movement of individual animals in the nation’s dairy, beef and pork herds that “it is impossible to track the birth and movements of offspring of cloned animals.”

Martin said the company supports the supply-chain management system announced by biotech firms in 2007 and doesn’t anticipate that meat from cloned animals will show up in the marketplace.

In 2007, ViaGen and Trans Ova Genetics put a Supply Chain Management program into place to identify and register their cattle and pig clones to meet processor and retailer requirements.

Blake Russell, CEO of Texas-based ViaGen, told Food Safety News that the program was developed in consultation and cooperation with all segments of the U.S. food industry, and that it enjoys USDA “process-verified” status under a marketing-based program.

Even so, Russell said that “it’s not feasible” to i
mplement a traceability system for the offspring of animals produced using cloning technology, nor is it necessary to do so in the U.S. in accordance with the FDA Risk Assessment released in January 2008.

Considering that cow clones, which can cost up to $150,000 or more, “aren’t just standing out there in the field looking good,” but rather being used to breed a farmer’s best cows, it’s only logical to assume that meat from their offspring has gone into the marketplace.

“We don’t know what’s in the marketplace because the USDA isn’t looking,” said Hanson of the Center for Food Safety.

But SEK’s Coover described the thousands of clone offspring likely sold for meat, compared to the millions of non-clone animals sold for meat in this country, as miniscule.

The FDA agrees with Coover on that count. Pointing to several press accounts that quoted farmers and others who said they’ve sold clone offspring to be slaughtered for food, the agency put the estimate of clone offspring sent to slaughter in the hundreds or even thousands. But the agency also said that’s just a small fraction of the total number of U.S. livestock slaughtered overall in 2007, for example — 34 million cattle and 109 million hogs.

What’s different about clones and their offspring

Coover told Food Safety News that the reason clones can have higher abnormalities than their offspring is based on how the embryos are cultured.

“That’s done in a lab and doesn’t mimic the environment in a living animal,” he said.

But he said that by the time the clones’ offspring have been born, the genes “have reset,” a comment that echoes FDA’s assessment on clone offspring.

“Certainly, the offspring of clones are ‘unremarkable’ when compared to conventionally produced animals,” Coover said. “They don’t just look like ‘normal’ animals. They are normal animals.”

What about the EU?

For awhile it was looking like it was going to be a “Green Light – Go” for meat and milk from clones and their offspring in the EU marketplace.

In 2008, the European Food Safety Authority released a report saying that there was “no indication that differences exist in terms of food safety for meat and milk of clones and their progeny compared with those from conventionally bred animals.”

That opinion was based on the assumption that meat and milk are derived from healthy animals subject to “relevant food-safety controls.”

That concurs with the FDA’s benchmark for food safety: Meat or milk from a healthy animal is safe to eat.

Following up on its earlier opinion, the European Food Safety Authority in 2009, and then again last fall, said that no new scientific information had become available that would require it to change its position about the safety of food products from animal clones and their offspring.

At the time, one of the commissioners said that the proposed ban was based on animal welfare, not food safety.

The European Commission’s report, which was sent to the European Parliament and Council, concluded with two proposals that delivered a strong blow to cloning — at least temporarily.

The first one called for a temporary suspension of cloning for the reproduction of all food-producing animals, the use of clones of these animals, and the marketing of food from clones.

The second one called for establishing a system to trace imports of semen and embryos to allow farmers and industry to set up a data bank(s) of offspring in the EU.

Even so, the commission proposed allowing imports of food products from the offspring of clones, as well as semen and embryos from clones for breeding.

Under the proposal, the commission would monitor the scientific and technological development of cloning during a 5-year review period to assess whether, when and under what conditions these provisional measures could be removed.

Early this month, things got dicier yet when European Parliament Vice-President Gianni Pittella, who chairs the negotiating delegation on novel foods and cloning, said that the EP is aiming for a legal binding solution that makes it clear that no food from cloned animals — or their descendants — can go into the marketplace.

In an email to Food Safety News, Pittella also said that he has urged Member States to recognize that it wouldn’t be enough to ban food only from cloned animals and that it’s important to take into account the general right of consumers for clear and transparent information.

If the EU can’t come up with a compromise by the end of March, the commission will have to go back to the drawing board. If that’s the case, it could craft new proposals for the Novel Foods Regulation that omit the questions of cloning and nanotechnology.

The Novel Foods regulation was crafted before technologies such as cloning and nanotechnology emerged on the scene.

U.S. reaction

The Center for Food Safety’s Jaydee Hanson was quick to say that if the latest proposals go through, it will be a good step toward slowing things down in the United States because of the amount of meat and milk-related products it exports.

The United States is the leader in cloning reproduction.

“From our vantage point, the best case scenario would be if the European Union doesn’t approve cloning and requires labeling,” Hanson said.

In the United States, the FDA says labeling is not necessary because food products from clones and their offspring are similar to that of non-clones and their offspring.

However, under the U.S. National Organic Program’s standards, food products from clones are not allowed to bear the organic label, although the NOP has not yet adopted a policy on food products from the offspring of clones.

In a statement on its website about the European Commission’s call for a 5-year moratorium, Mark Walton, president of of ViaGen, blasted the proposal for “limiting the ability of European animal breeders to compete in the global market.” And he warned that it could even impact its use worldwide.

“All governments must be careful so that one nation is not making de facto short-term political decisions that hinder the ability of the world’s farmers and ranchers to access this safe technology,” he said. “Cloning has the potential to improve global livestock production and increase farmer competitiveness.”

Along those same lines, Jim Herlihy, a spokesman for the U.S. Meat Export Federation, told Food Safety News that given projections that the world’s population will increase by more than 3 billion by the year 2050, “we would anticipate that initiatives like this (cloning), which will help improve both the efficiency and quality of food-animal production, will continue to gain broad acceptance.”

In an email to Food Safety News, ViaGen’s CEO Blake Russell said tha
t while the EU can do a number of things legislatively, it is difficult to imagine how it would intend to restrict the free flow of products from the offspring of cloned livestock.

He also pointed out that there is no test to determine if an animal is produced using cloning technology, or if the animal is the progeny or offspring of an animal produced using cloning technology. Likewise, there is no test to determine if an animal is produced using artificial insemination, is the result of embryo transfer or in vitro fertilization, or even if it was produced through natural mating.

“Cloned livestock and their offspring are located around the world, and their numbers are growing,” said Russell. “It is not feasible that one could restrict the offspring of cloned animals from ordinary trade.”

He believes that a formal acceptance of meat and milk from the offspring of cloned livestock “would likely be a positive for the industry as some are awaiting a green light from the international/European perspective.”

When discussing food safety, Russell said that the elite animals selected for cloning are typically healthier, more robust animals, which is “a positive approach to improving food safety.”

When asked about trade issues and the EU deliberations on cloning, SEK’s Coover said that producers have to be conscious of what their customers want and give them what they want. He warns that you can’t lie to your customers about this, especially if they’re buying food for their children.

According to a Eurobarometer opinion poll, a majority of EU citizens, while having an understanding of the concept of animal cloning, had a broadly negative perception of its use for food production.

According to the same poll, many of those surveyed were concerned about the lack of information about the long-term consequences of cloning, and many cited ethical concerns.

With that in mind, Coover said that “we need to say to the European Union that we can’t guarantee these aren’t products from clone offsprings.”

One way to look at it, he said, is that some consumers might consider products from non-clones and their offspring as specialty products and therefore be willing to pay more for them, as is the case with organic foods.

“I’d let the industry shake it out,” he said. “The government should stay the hell out of it.”

When he looks to the future of cloning, he said it’s currently not revolutionizing the livestock industry because there’s not yet a significant financial advantage to adopting it. But as it becomes more affordable, it will become more widespread.

“We’re seeing the crack of dawn on the horizon,” he said. “Just like tractors became such an advantage that people gave up their horses.”

He also doesn’t think politics can stop its progress.

“This technology is not leaving because a few people in the European Union don’t want it,” he said. “The advantages are becoming more obvious, even more so as it gets more affordable.”

He sees biotechnology as the next “huge wave.”

“We’re standing on the threshold of a biotech revolution,” he said. “This is where the industry is going. It will benefit us enormously just as computers have. It’s not going away.”

Who’s doing it?

According to the report on cloning from the European Commission to the European Parliament and Council, the United States, which has three major cloning companies, is the leader in cloning animals for food production.

In Argentina, cloning is being used for commercial purposes, and the country has no registry for clones. In Brazil, cloning is taking place only for research, not for food production.

China has expressed an interest in the technology and has imported clones from Australia, as well as from other countries.

Japan decided that it wouldn’t take any regulatory measures, such as prior certification or labeling of imported food from clones and their offspring. However, the country’s current voluntary moratorium on the domestic production of food products from clones and their offspring remains in place. Accordingly, the semen of cloned bulls is collected and stored but not used for commercial purposes.

Canada requires pre-market approval on a case-by-case basis for food from clones. Its current policy is being reviewed.

New Zealand has a moratorium keeping clones from entering the food chain.

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Photos courtesy of ViaGen: Photo 1: A cow cloned from Forever Lady 718, an internationally recognized Angus, tends to her traditionally bred calf. The cow sold for $170,000. Photo 2: Cloning procedure. Photo 3: K.C. was produced by cloning using a kidney cell taken from a carcass. She is shown here with her traditionally bred calf Sunshine, who was born December 17, 2004.